Medical Device Application for an External Device Using Data Logged at an Implantable Medical Device

ABSTRACT

A Medical Device Application (MDA) is disclosed for an external device (e.g., a cell phone) that can communicate with an Implantable Medical Device (IMD). The MDA receives data logged in the IMD, processes that data in manners reviewable by an IMD patient, and that can control the IMD based on such processed data. The MDA can use the logged data to adjust IMD therapy based on patient activity or posture, and allows a patient to learn optimal therapy settings for particular activities. The MDA can also use the logged data to allow a patient to review details about IMD battery performance, whether such battery is primary or rechargeable, and to control stimulation parameters based on that performance. The MDA also allows a patient to enter medicine dose information, to review the relationship between medicinal therapy and IMD therapy, and to adjust IMD therapy based on the dosing information.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.15/253,362, filed Aug. 31, 2016, which is a continuation of U.S.application Ser. No. 14/476,703, filed Sep. 3, 2014 (now U.S. Pat. No.9,433,796), which is a non-provisional of U.S. Provisional PatentApplication Ser. No. 61/873,314, filed Sep. 3, 2013. Priority is claimedto these applications, and they are incorporated herein by reference intheir entireties.

FIELD OF THE INVENTION

The present invention relates generally to implantable medical devicesystems, and more particularly to mobile external devices to be used inimplantable medical device systems.

BACKGROUND

Implantable stimulation devices deliver electrical stimuli to nerves andtissues for the therapy of various biological disorders, such aspacemakers to treat cardiac arrhythmia, defibrillators to treat cardiacfibrillation, cochlear stimulators to treat deafness, retinalstimulators to treat blindness, muscle stimulators to producecoordinated limb movement, spinal cord stimulators (SCS) to treatchronic pain, cortical and deep brain stimulators (DBS) to treat motorand psychological disorders, and other neural stimulators to treaturinary incontinence, sleep apnea, shoulder subluxation, etc. Thedescription that follows will generally focus on the use of theinvention within an SCS system, such as that disclosed in U.S. Pat. No.6,516,227. However, the present invention may find applicability withany implantable medical device (IMD) or in any implantable medicaldevice system.

As shown in FIG. 1, an SCS system typically includes an ImplantablePulse Generator (IPG) 10, which includes a biocompatible device case 12formed of titanium, for example. The case 12 typically holds thecircuitry and battery 14 necessary for the IPG to function. The IPG 10is coupled to electrodes 16 via one or more electrode leads 18 (two ofwhich are shown). The electrodes 16 are coupled to the IPG 10 at one ormore lead connectors 20 fixed in a header 22, which can comprise anepoxy for example. In the illustrated embodiment, there are sixteenelectrodes, although the number of leads and electrodes is applicationspecific and therefore can vary. In an SCS application, two electrodeleads 18 are typically implanted on the right and left side of the durawithin the patient's spinal cord. The proximal ends of the leads 18 arethen tunneled through the patient's tissue 60 (FIG. 2B) to a distantlocation, such as the buttocks, where the IPG case 12 is implanted, atwhich point the proximal ends are coupled to the lead connector(s) 20.

FIG. 2A shows a front view of an external controller 40 forcommunicating with the IPG 10, and FIG. 2B shows the external controller40 and IPG 10 in cross section. Two coils (antennas) are generallypresent in the IPG 10: a telemetry coil 30 used to transmit/receive datavia a bi-directional wireless communications link 55 to/from theexternal controller 40; and a charging coil 32 for recharging the IPG'srechargeable battery 14 using an external charger (not shown), which mayalso be incorporated with the external controller 40. Battery 14 mayalso be a non-rechargeable primary battery 14, in which case chargingcoil 32 would not be necessary. The coils 30 and 32 and other componentsnecessary for IPG operation are electrically coupled to a circuit board34. For example, an accelerometer 36 may be included within the IPG 10to monitor patient movement or other forces. The telemetry coil 30 canbe mounted within the header 22 of the IPG 10, or can be located withinthe case 12 as shown. The telemetry coil 30 can be coupled to telemetrycircuitry 38 to modulate and demodulate a serial string of data bitssent to or received from the external controller 40. IPG 10 would alsoinclude main control circuitry, such as a microcontroller 230 (describedlater with reference to FIG. 7B).

The external controller 40, such as a hand-held programmer or aclinician's programmer, is used to send or adjust the stimulationparameters the IPG 10 will provide to the patient (such as whichelectrodes 16 are active, whether such electrodes sink and sourcecurrent, and the pulse width, frequency, and intensity of pulses formedat the electrodes, etc.). The external controller 40 can also act as areceiver of data from the IPG 10, such as various data reporting on theIPG's status and the level of the IPG 10's battery 14. The externalcontroller 40 is itself powered by a battery 42, but could also bepowered by plugging it into a wall outlet for example. A Graphical UserInterface (GUI) similar to that used for a cell phone is provided tooperate the external controller 40, including buttons 44 and a display46. The external controller 40 also includes a data telemetry coil 48.These and other components 45 necessary for IPG operation areelectrically coupled in the external controller 40 to a circuit board47.

Wireless data transfer between the IPG 10 and the external controller 40typically takes place via magnetic inductive coupling between coils 30and 48, each of which can act as the transmitter or the receiver toenable two-way communication between the two devices. A Frequency ShiftKeying (FSK) protocol can be used to send data between the two coils 30and 48 via link 55. Although use of an FSK protocol along link 55 isdiscussed below, use of this protocol is not universal, and otherprotocols employing different forms of modulation can be used tocommunicate between an external controller and an IPG, as one skilled inthe art understands. Telemetry of data can occur transcutaneously thougha patient's tissue 60.

Historically, external medical devices such as external controller 40have been built by the manufacturer of the IPGs, and thus such externaldevices are generally dedicated to only communicate with such IPGs. Theinventor has realized that there are many commercial mobile devices,such as multi-function mobile cell phones and tablets, that have thenecessary configurable hardware and software to communicate usingshort-range protocols and thus may function as an external controllerfor an IPG or other implantable medical device. Using such mobiledevices as external controllers for an implantable medical device wouldbenefit both manufacturers and end users: manufacturers would not needto build dedicated external controllers that end users must buy, and endusers could control their IPGs without the inconvenience of having tocarry additional custom external controllers.

A Medical Device Application (MDA) for use on a mobile device, or othersuitably-powerful external device capable of communicating with an IPGor other implantable medical device, is disclosed with improvedfunctionality, which leverages the increased processing power and memoryof such mobile devices to improve patient communications with hisimplant; to improve patient control of his implant; and to provide apatient more-detailed information concerning operation of his implant.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an implantable pulse generator (IPG) in accordance with theprior art.

FIGS. 2A and 2B show an external controller and the manner in which itcommunicates with the IPG in accordance with the prior art.

FIG. 3A shows a mobile device in accordance with an embodiment of thepresent invention, and FIG. 3B shows the mobile device in wirelesscommunication with an IPG.

FIG. 4 shows an exemplary manner in which a Medical Device Application(MDA) can be selected on the mobile device via a mobile device GraphicalUser Interface (GUI).

FIG. 5 shows an MDA GUI of the mobile device to enable communicationsbetween the mobile device and the IPG.

FIG. 6 shows part of the MDA GUI providing advanced options of the MDA.

FIG. 7A shows an example of an IPG data log useable by the MDA 170, andFIG. 7B shows the IPG data log in the context of other IPG circuitry.

FIGS. 8A and 8B show patient activity advanced options of the MDA.

FIG. 9 shows medicine dosing advanced options of the MDA.

FIGS. 10A-10D show battery performance advanced options of the MDA.

DETAILED DESCRIPTION

FIG. 3A shows a mobile device 140, and FIG. 3B shows the mobile device140 in communication with an IPG 110 implanted in a patient 100 via abi-directional communication link 155. Communication link 155 may or maynot differ from link 55 established by a traditional dedicated externalcontroller 40 (FIGS. 2A and 2B), and the particulars of link 155 may bedictated by the type of short-range communication means used in themobile device 140 and in the IPG 110. IPG 110 may be the same as IPG 10discussed earlier, or may include modifications consistent withoperation of the invention, as described in further detail later. Themobile device 140 may be a commercial, multipurpose, consumer device,such as a cell phone, tablet, personal data assistant, laptop ornotebook computer, or like devices—essentially any mobile, hand-holdabledevice capable of functioning as an external controller for animplantable medical device. Examples include the Apple iPhone or iPad,Microsoft Surface, Nokia Lumia devices, Samsung Galaxy devices, orGoogle Android devices, for example.

Among other components and circuitry which will be described in furtherdetail later, the mobile device 140 has a Graphical User Interface (GUI)150. For example, mobile device 140 may have a display 142 fordisplaying information. Display 142 may also receive input from apatient if it is a touch screen that receives input from a finger orstylus. The mobile device 140 may also have buttons 144 for receivinginput from the patient, a speaker 146, and a microphone 148. The mobiledevice 140 may have one or more external ports 149, such as a USB portfor example, to connect the mobile device 140 to other devices. Althoughnot shown, such other devices can include for example chargers for themobile device's battery, other computer systems, memory cards, sticks,and dongles, etc.

The inventor has realized that an implantable medical device such as IPG10 (FIG. 1) typically logs copious amounts of data for various reasons.While such logged data can be retrieved from the IPG by a clinician orIPG manufacturer using special diagnostic tools, such data is typicallynot reviewable by a patient using a traditional external controller 40(FIGS. 2A and 2B). This is understandable, as traditional externalcontrollers 40 are typically relatively simple: they provide relativelysimple GUIs limited to sending stimulation parameters to the IPG, and topresenting limited data from the IPG, such as IPG battery status orperhaps information indicative of IPG status. Even if other logged datain the IPG were transmitted to the external controller 40, the externalcontroller 40 may lack the ability to process such data. Moreover,traditional external controllers 40 may also lack the memory to storesignificant amounts of such data transmitted from the IPG. However, ageneral-purpose mobile device 140 does not suffer from the samelimitations.

A Medical Device Application (MDA) is thus disclosed for a mobile deviceor other capable external controller (hereinafter “external device”)that allows for receipt of a greater variety and amount of data loggedin the IPG; that can process that received data in manners reviewable bya patient; and that can control the IPG based on such processed data. Inconjunction with such logged data, the MDA at the external device canpreferably automatically adjust the stimulation parameters provided tothe IPG based on patient activity or posture, as well as allow a patientto learn optimal stimulation parameters for particular activities. TheMDA can also use the logged IPG data to allow a patient to reviewfurther details about IPG battery performance, whether such battery isprimary or rechargeable, and to control stimulation parameters based onthat performance if necessary. Other aspects of the MDA allow a patientto enter dosing information concerning medicines the patient is taking;to review the relationship between such medicinal therapy andstimulation therapy provided by the IPG; and to automatically adjust thestimulation parameters provided by the IPG based on dosing information.

As shown in FIG. 4, MDA 170 can be wirelessly downloaded to a patient'sexternal device 140 by standard means (e.g., from the Internet), but mayalso be provided at a physical port (e.g., 149) on the external device140, which can receive cables, or portable memory devices such as memorysticks or memory cards to load the MDA 170 into the external device 140.The MDA 170 once downloaded or loaded into the external device 140 canappear as an icon in the external device's GUI 150, and can be selectedby the patient in a typical fashion, such as by touching the display 142or buttons 144. Icons for other downloaded applications 172 that thepatient can select may also be displayed. The MDA 170 can also beprovided to the external device 140 in different manners.

Different types of external devices (e.g., mobile devices) comprisedifferent hardware platforms and run different operating systems. Assuch, different external devices may require different MDAs 170customized to that operating system or hardware platform. Additionally,different MDAs may be needed in light of the capabilities of theimplantable medical device and the therapy it provides. For example, ifthe implantable medical device is an IPG, the MDA will provide asuitable GUI for communicating with that device, such as by providingoptions to send or adjust stimulation therapy settings. A suitable MDA170 is likely (but not necessarily) provided to a patient by themanufacturer of the implantable medical device, although the MDA couldbe downloaded to the external device 140 from a number of sources, suchas a manufacturer's website or an “app store” that supports applicationswritten for the operating system of the patient's external device 140.

If MDA 170 is selected and executed on the external device 140, an MDAGUI 180 is presented that provides basic IPG-control functionality, asshown in FIG. 5. For example, the MDA GUI 180 may present options tostart or stop stimulation; to increase or decrease the intensity ofstimulation; to check the IPG's current battery status (e.g., itsvoltage Vbat); to change other stimulation parameters (such as activeelectrodes, polarity, frequency, and pulse width, etc.); or to check theIPG's status, as are typical. Such options are generally provided by theGUIs of traditional external controllers (40; FIGS. 2A and 2B) as well.An option to exit the MDA may also be provided (182), which will end theIPG communication session and return to the external device GUI 150 ofFIG. 4.

MDA GUI 180 may additionally include a selectable option 184 to providecontraindication information to the patient, similar to the techniquedisclosed in U.S. Pat. No. 8,588,925, which is incorporated herein byreference. The '925 patent explains that “contraindication information”can be stored in a traditional dedicated external controller, such asthe external controller 40 of FIGS. 2A and 2B, allowing such informationto be reviewed on the external controller 40 itself, or provided fromthe external controller 40 (e.g., by cable, by a memory stick,wirelessly, etc.) to another computer device or system and reviewedthere (such as a clinician's computer). Such “contraindicationinformation” can comprise information that a patient or clinician mightwish to review when assessing the compatibility of a given therapeuticor diagnostic technique or other activity with the patient's implant,such as: the patient or clinician's manuals for the implant system,including the manuals for the implant and any associated externaldevices (e.g., remote controllers or external chargers); any specificcontraindicated therapeutic or diagnostic techniques or activities;contact information for the manufacturer of the implant system or itsservice representative; clinician contact information, for example thecontact information of the clinician who implanted the implant, oranother clinician having information relevant to the use of particulartherapeutic or diagnostic techniques or other contraindicated orcompatible activities; clinician instructions regarding therapeutic ordiagnostic techniques or activities compatible with or contraindicatedby the patient's implant; patient history or patient records relevant toa particular therapeutic or diagnostic techniques or activitiescompatible with or contraindicated by the patient's implant; etc.“Contraindication indication” can also indicate procedures or activitiesthat are compatible with the patient's implant as well as those that areprohibited, at least to some conditional degree. Similar to the teachingof the '925 patent, contraindication information may be stored in theexternal device 140, and via option 184 may be shown on its display 142or provided from the external device (e.g., wirelessly, using itsshort-range communication means as explained earlier) to anothercomputer device or system (not shown).

Another option in the MDA GUI 180 of pertinence to the present inventionis advanced options 190, which when selected takes the patient to anadvanced options GUI 200 in the MDA 170 as shown in FIG. 6. Shown arethree advanced options provided by the MDA 170: an activity option 202,a medicine dose option 204, and an IPG battery performance option 206,all of which are discussed below. An option to return to the previousscreen 208 in the MDA 170 (i.e., to FIG. 5) may also be present.

An example of an IPG data log 220 useable by the MDA 170, andparticularly by the advanced options presented in GUI 200, is shown inFIG. 7A, and IPG data log 220 is shown in the context of other IPGcircuitry in FIG. 7B. While an IPG might in some embodiments keepseparate logs for separate functions (e.g., a stimulation parameter log,a charging log, etc.), these are consolidated in one log 220 in FIG. 7Afor ease of illustration. As shown, data is periodically logged and timestamped (t) by the IPG, which may occur at any reasonable interval.Periodic logging however is not strictly necessary, and instead data mayonly be logged upon the occurrence of an event in the IPG, such as achange in one of the parameters stored in the log 220. Also, not all ofthe illustrated parameters may be logged in 220 at every given entry,and so they can be logged at different times or on different timescales.

At each time-stamped entry, the control circuitry 230 (FIG. 7B) in theIPG (e.g., a microcontroller) logs pertinent parameters in the IPG datalog 220, which may be stored in a memory 232 within or accessible by thecontrol circuitry 230. Such parameters may include stimulationparameters such as pulse intensity (I), pulse frequency (f), pulse width(pw), active electrodes and their polarities (E1+(anode), E7−(cathode)), which stimulation parameters are better appreciated uponreview of the pulse waveforms in FIG. 7B. As shown in FIG. 7B, thecontrol circuitry 230 in the IPG has loaded current stimulationparameters (e.g., those last listed in the IPG data log 220) to astimulation timing channel 234. The timing channel 234 controls currentgeneration circuitry 236 in the IPG to create the pulses as specifiedthrough the patient's tissue 60 at the active electrodes with thecorrect polarities. As is known, the current generation circuitry 236can comprise one or more controllable current sources (PDAC(s)) andcurrent sinks (NDAC(s)), which can be connected to the active electrodes(e.g., E1 and E7) by a switch matrix 238. The resulting pulses areillustrated simply in FIG. 7B. For example, they are not depicted asbi-phasic pulses and do not show provision of charge recovery duringnon-pulse periods, as typically occurs in an IPG. See, e.g., U.S. PatentApplication Publication 2013/0184794 for further details.

Returning to FIG. 7A, further shown in the IPG data log 220 are entriesrelated to patient activity, which are provided for example by theaccelerometer 36 in the IPG discussed earlier. The data from theaccelerometer 36 is illustrated as an activity amplitude (A) based onthe magnitude of the forces that the accelerometer detects. Althoughaccelerometer 36 may be able to detect force magnitudes in threedirections (e.g., Ax, Ay, and Az), only a single activity amplitude (A)is shown in IPG data log 220 for simplicity. Also provided in IPG datalog 220 are electrode impedance fingerprints (FP), which are useful todetermining patient posture, as described in U.S. patent applicationSer. No. 14/024,276, filed Sep. 11, 2013, which is incorporated hereinby reference in its entirety. Parameters A and FP are collectivelyreferred to herein as “activity parameters.” The voltage of the battery14 in the IPG (Vbat) is also measured by the IPG and stored in log 220,as is the battery charge current (Ibat), which is explained furtherbelow.

The IPG data log 220 also preferably contains data relevant to wirelesscharging of the battery 14 (FIGS. 1 and 2B), assuming it is arechargeable and not a primary battery. Referring to FIG. 7B, arechargeable battery 14 can be charged by an external charger, which isnot shown but which is well known. See, e.g., U.S. Patent ApplicationPublication 2013/0096652. An external charger creating a AC magneticfield, which is received at the IPG charging coil 32, where it isrectified 240 and used to create a battery charging current (Ibat) tocharge the battery 14, perhaps under the control of battery charging andprotection circuitry 242. Wireless charging in this manner only occursfrom time to time as needed, and so in IPG data log 220 it is seen thatIbat is only reported during charging, which can be made known to thecontrol circuitry 230 in the IPG via the charging and protectioncircuitry 242. Ibat is generally indicative of how intensely the battery14 is being charged, which is a function of the coupling between theexternal charger and the IPG. Other data indicative of battery chargingintensity could be logged by the IPG in log 220 as well. If the battery14 in the IPG is a primary battery, battery charge current data would beomitted from the log 220.

Other IPG data could be provided in log 220 as well, and likely would belogged in an IPG implementation, such as IPG mode data, error codes,etc. However, the example data in log 220 is sufficient to illustrateoperation of the algorithms performed by the MDA 170 in the externaldevice 140.

As noted earlier, the MDA 170 uses data from the IPG data log 220, andso this data is transmitted from the IPG to the external device 140 atsome point during communication sessions. This can occur at differenttimes and in different manners. In one example, when the patientexecutes the MDA 170 (FIG. 4) and the MDA GUI 180 appears (FIG. 5), theexternal device 140 may “handshake” with the IPG in a traditionalfashion to establish communication link 155. In this regard, theexternal device 140 includes an antenna 164 and telemetry circuitry 162compliant with short-range communications and protocols used on link155. The IPG also includes an antenna 244 and telemetry circuitry 246compliant with communications on link 155. Note that the IPG antenna 244and telemetry circuitry 246 may be different from the antenna coil 30and telemetry circuitry 38 described earlier for IPG 10, but this is notnecessarily the case, particularly if the external device 140 is capableof communicating with the IPG via link 55 as discussed earlier.

After handshaking, the external device 140 can instruct the IPG via link155/55 to upload its log 220. Alternatively, the IPG can upload the log220 unilaterally when it recognizes that it can communicate with theexternal device 140. The MDA 170 may provide a message on the MDA GUI180 to inform the patient that uploading of the log 220 is occurring,and that the patient should wait before using MDA 170 on the externaldevice 140 to control his IPG.

Transmission of the IPG data log 220 can occur at other times duringcommunication sessions as well. For example, the MDA 170 may causetransfer of the log 220 only when it is needed by the MDA 170, such aswhen any of the advanced options in GUI 200 (FIG. 6; 202, 204, or 206)are chosen. Transmission of the log 220 to the external device 140 canalso occur at other convenient times during a communication session,such as when the bi-directional communication link 155/55 isestablished, but is not being used at the moment.

The IPG can either upload its log 220 to the external device 140 in itsentirety, or may record the last entry transmitted, and begin withtransmission of subsequent entries. For example, if the IPG records thatit sent its log 220 up through time t11 in its last communicationsession with the external device 140, it may start uploading at entriesstarting from time t12 in a next communication session. The IPG may alsoclear entries at time t11 and earlier from its log 220 once they havebeen confirmed as received at the external device 140, which may bereasonable because the memory 232 storing the log 220 may be small givenspace constraints in the IPG.

As shown in FIG. 7B, the external device 140 preferably keeps all IPGlog data reported to it in a file 250 accessible by the MDA 170. ThisIPG log file 250 can thus grow as the IPG uploads new data from log 220from time to time during different communication sessions. Because theexternal device 140 has ample memory 252, storing a growing IPG log file250 is generally not a concern for the external device 140.Alternatively, the MDA 170 may limit the size of the IPG log file 250accordingly, such as to one year's worth of data, and delete olderentries in its file. If the time base of the IPG has drifted, changed,or reset, for some reason (e.g., because its rechargeable battery 14 hasdepleted), the IPG can resynchronize its time base with the assistanceof the external device 140 and correct the time stamps in its log 220,as disclosed in U.S. Pat. No. 8,065,019. This ensures that entries inthe IPG log file 250 are properly chronologized at the external device140. As one skilled in the art will appreciate, MDA 170 is executable bycontrol circuitry 160 (e.g., a microcontroller) in the external device140, and may be stored within the control circuitry (as microcode) ormade accessible to the control circuitry (e.g., in memory 252).

FIG. 8A illustrates the GUI 300 that appears in the MDA 170 when the“activity” advanced option 202 (FIG. 6) is selected by the patient. Thisoption 202 is used to control one or more stimulation parametersoperating in the IPG based on a particular patient activity. Onlycontrol of a single stimulation parameter—stimulation intensity (I)—isdiscussed here for simplicity, even though other stimulation parameters(f, pw, Ex, etc.) could be similarly controlled. Such control by theexternal device 140 can occur in different ways using at least some ofthe data in IPG log 220. As shown, the activity GUI 300 includes variousactivities 304 that a patient could be engaged in, such as running,sitting, swimming, sleeping, etc. When an activity 304 is selected bythe patient, MDA 170 will cause the external device 140 to transmitoptimal stimulation parameters for the patient and for that activity tothe IPG.

Learn activity option 302 allows the MDA 170 to learn (i.e., correlate)optimal intensities for the different activities. If the patient isabout to begin an activity, for example running, he can select this 302,which will take him to an activity learning GUI 320, as shown to theleft in FIG. 8A. This activity learning GUI 320 provides differentactivities 322 that can be learned, including an option to allow thepatient to enter a “new” activity not presently listed, which onceentered would show on the activity GUI 300 and the activity learning GUI320 as a selectable option.

In the following example, assume the patient selects the “run” learnactivity option 322, and begins running. During learning, the MDA 170can receive the IPG data log 220 and/or can consider information alreadyknown to the MDA 170, regarding the stimulation parameters (e.g.,intensity), which the patient can change using the external device 140as he runs to levels that are comfortable. Specifically, the MDA 170 cancreate an activity learning file 324, which records intensity during theactivity. Activity parameters A and FP (from log 220) may also be storedin the activity learning file 324, as is useful for reasons to beexplained shortly. As shown, the MDA 170 time stamps entries in theactivity learning file 324. Once the patient is done running, he canselect the stop learning option 326, at which point the MDA 170 willstop populating the activity learning file 324. However, the activitylearning file 324 can grow in length at the MDA 170. For example, if thepatient runs again tomorrow, he can again select the run learning option322 and begin running, and the MDA 170 will continue populating theactivity learning file 324, as it is beneficial to provide the MDA 170with further data concerning this activity.

Intensity values (I) in the activity learning file 324 can come eitherfrom the MDA 170, i.e., from the external device 140, or because theexternal device 140 has access to the log file 250, it can also comefrom that file, and ultimately from the IPG (220). In this regard, MDA170 need not directly record or receive this intensity data during theactivity (even if known to the MDA 170) as it can later be procured fromthe IPG data log 220/log file 250 and reconciled with the activitylearning file 324. That is, time stamps in the activity learning file324 can later (e.g., after the activity) be populated with the valuesfor I by pulling entries from the log file 250 having the same timestamps, or time stamps that are close in time. In this regard, note thatactivity learning file 324 may, before such reconciliation, merelycomprise the time stamps or a time period denoting the starting andstopping of learning the activity.

Eventually, when enough data is present in the activity learning file324, the MDA 170 can average the values for the intensity stored in thefile 324, and create an optimal intensity (Iopt) for that activity. TheMDA 170 might then also present the activity as a control option 304 onthe activity GUI 300 to allow the patient to control his IPG inaccordance with what was learned during the activity. For example, afterlearning the patient's intensity settings while running (324), anddetermining Iopt, selecting the run control option 304 will cause Ioptto be sent to the IPG for execution.

The auto-adjust intensity option 306 in the activity GUI 300 alsocontrols intensity based on patient activity, but can do so withoutknowledge of the particular activity the patient is engaged in. Theauto-adjust intensity option 306 controls the IPG based on the patient'spresent level of activity (A′, as provided by the IPG's accelerometer36) and posture (FP′, as provided by the electrode impedancefingerprint) reported to the external device 140 from the IPG. (Primesymbols here differentiate current values x′ from historical values x).Thus, when selected, the MDA 170 calls on the IPG to provide thesecurrent activity parameters A′ and FP′. These activity parameters mayonly be sent once by the IPG, or they may be sent on a continuing basisat suitable intervals to allow the IPG to be controlled as patientactivity changes.

Such auto-adjustment is facilitated by an activity history file 238. Asnoted above, the activity learning file(s) 324 (e.g., one per activity,or just one file 324 including associations with the activities) canadditionally include activity parameters A and FP, which are ultimatelyincluded in the IPG data log 220, and eventually provided to theexternal device 140 as IPG data file 250. These activity file(s) 324 xcan then be consolidated into the activity history file 328, whichassociates the intensities (Ix) used by the patient with differentactivity parameters Ax and FPx measured at that time. Notice that theactivity history file 328 need not include the time stamps (t). The MDA170 can then receive and review the present activity parameters A′ andFP′ from the IPG to determine an optimal intensity (Iopt) using theactivity history file 328. In a simple example, this may comprisesearching the activity history file 328 for entries having values Ax andFPx that are similar to A′ and FP' currently being reported by the IPG,and reviewing (e.g., averaging) the corresponding intensities (Ix) forthose entries; more complicated statistics could also be used. Oncedetermined, the value for Iopt can be transmitted to the IPG where it isexecuted. If patient activity doesn't remain constant (e.g., if thepatient begins running faster, or starts a new activity such asswimming), new current values for A′ and FP′ are received from the IPG,and Iopt is updated and transmitted to the IPG after consulting theactivity history file 328. In effect, the auto-adjust intensity option306 provides Iopt to the IPG by consulting the activity history file 328(or simply by pulling the relevant information from the activitylearning file(s) 324) and determining an intensity that was usedpreviously by the patient for a similar activity level, and which waspresumably suitable for the patient at that earlier time.

Review of fingerprint data (FP) is particularly useful with theauto-adjust intensity option 306, because not all patient activities canbe differentiated based on movement alone. For example, both sitting andsleeping involve little patient movement, and so activity amplitude A(likely near zero during these activities) may be of little use. Yet,the different postures provided by these activities may well result indifferent fingerprints in the IPG that warrant different stimulationparameters, as explained in the '276 Application incorporated above.

Some activities may have natural or desired stages (sub-activities)where the optimal patient stimulation may be different for eachsub-activity. The activity of running, for example, may comprise threesub-activities: warm up, active running, and cool down. Learning theoptimal stimulation for each sub-activity allows the MDA 170 to transmitupdated stimulation parameters to the IPG when those each sub-activitiesoccur.

FIG. 8B shows an example of a sub-activity GUI 330 for the activity ofrunning, which may be invoked, for example, by a patient selecting therun learn option 322 (FIG. 8A). Sub-activity GUI 330 provides options332 for each sub-activity, which selections can be used to inform theMDA 170 when transitions between the sub-activities are taking place orare likely to take place. Thus, when one sub-activity is selected (e.g.,warm up), the patient can at GUI 340 enter a preset time as to how longthis sub-activity typically takes. Alternatively, the patient can usethe start/stop option to inform the MDA 170 as to when the patient hasbegun and ended the sub-activity—in effect, to time the sub-activity. Ineither case, the patient performs the activity, or individualsub-activities, and activity learning file(s) 324 is/are created, andwith portions being associated with the different sub-activities.

After several iterations of such learning, the patient will eventuallybe able to select the activity 304 from the activity GUI 300 (FIG. 8A),with the MDA 170 adjusting the stimulation parameters to coincide witheach sub-activity. For example, MDA 170 may upon consulting the activitylearning file(s) 324 determine an Iopt1 for the warm up sub-activity;Iopt2 for the active running sub-activity; and Iopt3 for the cool downsub-activity.

The MDA 170 can understand the transition between differentsub-activities—and hence when Iopt for each sub-activity should betransmitted to the IPG—in different manners. In one example, The MDA 170may determine transitions based on the anticipated time spent performingeach sub-activity. The anticipated sub-activity time may be determinedbased on historical data, i.e., averaging the time previously spent ineach sub-activity as gleaned from the activity learning file(s) 324, orthe sub-activity time may be preset by the patient as discussed earlier.

In another example, the MDA 170 may determine a transition from onesub-activity to another as a function of A′ and FP′ presently beingreported from the IPG. For example, if the activity learning file 324also includes activity parameters (A, FP) (FIG. 8A), the MDA 170 canmonitor the currently-reported activity parameters (A′, FP′); comparethem to the stored activity parameters in the file(s) 324 for eachsub-activity to determine a sub-activity having similar values; andautomatically change the optimal stimulation (Iopt) accordingly, whichagain can be different for each sub-activity. In this regard, note thatan activity history file 328 can be created from the activity learningfile(s) 324 for each sub-activity—i.e., as populated with data I, A, andFP occurring during the particular sub-activity.

FIG. 9 illustrates the GUI 400 that appears in the MDA 170 when the“medicine dose” advanced option 204 (FIG. 6) is selected by the patient.In this regard, patients with IPGs may be experiencing pain (e.g., in anSCS application) and typically have some experience with taking certainmedicines, such as analgesics. Patients with IPGs may also experienceother symptoms (e.g., tremors in a DBS application) and take other typesof medications to alleviate those symptoms as well. An IPG is oftenintended to supplant the need for such medications, although some IPGpatients may still continue to take (preferably reduced) amounts ofmedications even after receipt of an IPG. Medicine dose advanced option204 assists patients in understanding the relationship betweenstimulation therapy and medicinal therapy, and to control thestimulation parameters of the IPG based on patient medicine intake.Again, only control of the stimulation parameter of intensity isdiscussed for simplicity, even though other stimulation parameters couldbe controlled as well.

Medicine dose GUI 400 includes an enter dose option 402 to allow apatient to enter a particular dose (D) of a medication taken. A patientwould preferably access this option 402 as soon as she takes hermedicine, but the dose could be entered later, in which case the patientwould also preferably enter the approximate time the medicine was taken.The doses are time stamped (or are associated with a time entered by thepatient) and stored in a dosing file 404 by the MDA 170. Also in thedosing file 404 is stimulation intensity (I), which, as before, can beprovided by the MDA 170 as the patient uses it to change stimulation, orwhich can be provided by the IPG log file 250 (IPG data log 220 astransmitted to the external device 140) and later reconciled with thedosing file 404 via the timestamps (t). Note that patients may adjustintensity more frequently than they may take their medicine, and so manyof the dose entries in dosing file 404 may be blank.

After a sufficient amount of data is entered into the dosing file 404,the patient can select a display correlation option 406, which uses thedosing file 404 to correlate medicine dose (D) with intensity (I). Inthis regard, the MDA 170 may correlate I and D in the dosing file 404(I=f(D)), such as by using linear regression analysis or other knowncurve-fitting techniques (if a linear relationship is not apparent) todetermine a dose-versus-stimulation curve 408, which can be displayed142 on the external device 140 for the patient.

The MDA 170 may make reasonable assumptions when assessing the data inthe dosing file 404 to determine the data points (D, I) to use inestablishing this correlation. For example, the MDA 170 may average allvalues for I appearing after a given dose in the dosing file 404. Forinstance, intensities 120-136 may be averaged and associated with doseD20 to create one (D, I) data point upon which the correlation curve 408is based. Or realizing that a dose may not be therapeutically effectivein a patient until after some time, the MDA 170 may instead averageslightly-later values for I, and perhaps even those occurring after anext dose D37 (e.g., I22-I38). The MDA 170 may also ignore data in thedosing file 404 that occurs when a dose is changed, because a steadystate of the medicine in the patient cannot be assured. For example, ifD2=D20=D37=30 mg, and D58=D72=D91=20 mg, 158-171 may be ignored, or maybe associated with a factitious dose of 25 mg between the interveningdoses. In any event, curve 408 can be useful to the patient as well asher clinician to understand how well IPG therapy is supplementing orreducing medicinal therapy.

Curve 408 is also useful in forecasting IPG stimulation parameters onceIPG therapy overtakes the patient's medicinal therapy. In this regard,it is typical for IPG patients to continue to take their medicationafter receiving their IPGs, with the dose reduced over time asstimulation is gradually increased. Curve 408 can track how this isprogressing, and can provide an estimate for the baseline stimulationparameters (e.g., a baseline intensity Ib) a patient can expect to usein her IPG once she is no longer taking medicine (i.e., when D=0).

Curve 408 can also be used to control the IPG, which is particularlyuseful for those patients that still require medicinal therapy inaddition to IPG therapy. In this regard, a patient can select anauto-adjust intensity option 410. Upon selection of this option 410, theMDA 170 will retrieve the current (last) dose (D′) in the dosing file404, calculate or update the dose-versus-stimulation curve 408 ifnecessary, select an Iopt corresponding to the current dose D′ (usingcurve 408), and transmit Iopt to the IPG for execution. When determiningIopt, the MDA 170 preferably considers the time stamps in the dosingfile 404. For example, if the last entered dose in the dosing file wasthree days before selection of the auto-adjust intensity option 410, theMDA 170 may assume that the medicine has worn off and that the currentdose in the patient is zero despite the last entry in the dosing file,and provide Iopt=Ib to the IPG.

The MDA 170 might also be programmed with other information, such asdose concentration curves (including ramp to peak concentration andelimination half-life) of the patient's medicine, which would allow theMDA 170 to even more accurately deduce the dose-versus-stimulationcorrelation represented by curve 408, and to more accurately provideIopt during auto-adjustment. For example, if the MDA 170 understandsthat the last dose D was taken t hours ago, the MDA 170 may estimatethat the patient's current dose level is D′ (e.g., less than D), and canthen use curve 408 to determine Iopt which is then transmitted to theIPG. As time increases without entry of another dose in the dosing file404, it would be expected that this assessment would cause Iopt toincrease over the time increase.

FIG. 10A shows a GUI 500 for the IPG battery performance advanced option206 provided earlier (FIG. 6). This aspect of MDA 170 can vary dependingwhether the battery 14 in the IPG is a non-rechargeable primary batteryor a battery that is rechargeable (e.g., by the external chargerdescribed earlier). Options 502 and 504 for both types of batteries areshown in FIG. 10A. In one implementation, the MDA 170 when initializedon the external device 140 could ask the patient which type of battery14 is used in his IPG, and subsequently only enable and present the GUI520 (FIG. 10B) or 540 (FIG. 10C) corresponding to option 502 or 504.

A primary battery performance GUI 520 results from selecting option 502,and is shown in FIG. 10B. Also shown in FIG. 10B is a primary batteryhistory file 522 maintained by the MDA 170, which includes thestimulation parameters (I, f, pw, active electrodes and polarities) andthe battery voltage, Vbat, which are time stamped. Vbat is measured atand reported from the IPG (e.g., as part of IPG data log 220), and ispreferably accessible to the MDA 170 via IPG file log 250. Thestimulation parameters can likewise be reported from the IPG, or alreadyknown by the MDA 170. If the stimulation parameters come from the MDA170, the battery voltages can be reconciled and included in the primarybattery history file 522 using the time stamps (t) as discussedpreviously.

As shown in FIG. 10B, the primary battery performance GUI 520 mayimmediately notify the patient of certain useful parameters that apatient might wish to review (524), such when the battery 14 is expectedto reach the end of its life based on the historical usage data in theprimary battery history file 522. This is important, as the patient willneed to have his IPG removed and a new IPG implanted at this time.Review of the end of life may also be a selectable option.

The end of life calculation as presented at 524 can be performed by theMDA 170 in several different ways. In a simple way depicted at thebottom of FIG. 10B, the MDA 170 may curve fit Vbat versus time 526 usingthe data in the primary battery history file, and extrapolate the timefrom the present (t′) when the battery voltage will reach a minimumoperational voltage, Vbat(min), for satisfactory IPG operation (tEoL).Viewing a graph of Vbat versus time (on display 142) is also selectableas an option 528, which may include curve 526 as well as the actualhistorical performance of Vbat. The battery versus time correlation 526and its extrapolation to determine end of life may not consider theentirety of the data in the primary battery history file 522, but mayonly include data over a recent time period (e.g., one month) betterindicative of the patient's recent current stimulation parameters andhence IPG power draw, which may historically vary.

Because the discharge curves of primary batteries (i.e., Vbat) arenon-linear and thus may be difficult to curve fit, the MDA 170 mayemploy other means to estimate primary battery end of life thatconsiders the stimulation parameters in the primary battery history file522. For example, the MDA 170 can calculate the charge C expended bybattery 14 in the IPG for each entry in the primary battery history file522. The charge for each therapeutic pulse issued by the IPG comprisesthe intensity (I) times the pulse width (pw). To determine the totalcharge expended for each entry in file 522, this per-pulse charge ismultiplied by the number of pulses the IPG delivered during the entry,which comprises the frequency (f) times the duration of the entry. Forexample, note from the primary battery history file 522 that stimulationparameters I3, f3, and pw3 were in effect in the IPG from time t3 to t4.The total charge expended by the battery 14 during this entry is thus:C3=I3*pw3*f3*(t4−t3), which value can be added to the primary batteryhistory file 522 as shown. The number of active electrodes (which may bemore than two) may also be relevant to this charge calculation, althoughit is assumed for simplicity that the intensity I in the primary batteryhistory file 522 comprises the total current provided to the patient byall active electrodes.

The MDA 170 may then curve fit 530 data points (Cx, tx) as set forth inthe primary battery history file 522, as shown at the bottom right inFIG. 10B. Curve 530 can be used by the MDA 170 in conjunction with thetotal capacity of the battery 14 (Cbat) and the total charge expended bythe battery to date (C′) to estimate the end of life (tEoL) of theprimary battery. Battery capacity Cbat, normally expressed in amp-hours,is typically known and thus can be provided or programmed into the MDA170. The total charge (C′) used by the battery 14 up to the present time(t′) can be determined either by adding the charge values in the primarybattery history file 522 from inception (ti) to present time (t′), or bydetermining the area under curve 530 between times ti and t′. Thisallows the charge remaining in the battery (Cr) to be determined(Cr=Cbat−C′). Curve 530 can then be extrapolated, with tEol beingdetermined as the time at which the area under curve 530 from thepresent (t′) equals Cr. Having the primary battery history file 522 alsotrack the cumulative charge used at each entry, or the charge rate, canalso be useful in these calculations as one skilled in the art willappreciate, although this is not shown.

Curve 530 need not be curve fit using all historical data in the primarybattery history file. Instead, only the patient's current stimulationparameters, or stimulation parameters used recently (e.g., one month),may be used to provide a estimation for tEoL that is consistent with thestimulation parameters being currently or recently used. For example, ifthe patient is presently using more power-intensive stimulationparameters than he has historically, the end of life calculation willreflect this, as shown in extrapolation 532 in the graph in FIG. 10B.

If the battery 14 it approaching its end of life, the set end of lifeoption 534 provided in the primary battery performance GUI 520 allowsthe patient the ability to ensure that at least some level ofstimulation will be provided by his IPG up to a convenient date. Assumefor example on Jan. 1, 2014 that the end of life estimation (tEoL) is 30days away (Jan. 31, 2014), while the patient is away on business. Thepatient can use this option 534 to enter a more convenient date, such asone that is 50 days away (Feb. 20, 2014), after the patient hasreturned. When the patient enters this new date, the MDA 170 will adjustthe stimulation parameters accordingly and send them to the IPG.

The MDA 170 can adjust the stimulation parameters by determining thetime to the currently-estimated end of life (i.e., 30 days); the time tothe desired end of life entered by the patient (i.e., 50 days); andtheir ratio to determine a scalar (0.6). The MDA 170 can then use thisratio to scale the stimulation parameters accordingly. This may involvejust scaling the patient's current intensity setting (I), but pulsewidth (pw) or frequency (f) could also be scaled, or all three to aslighter degree. Or the MDA 170 could determine average simulationparameters values from the primary battery history file 522, and scalethese appropriately and transmit them to the IPG.

The MDA 170 at this point might also allow the patient to choose whichstimulation parameters to scale consistent with the scalar calculated,so the patient can try out different stimulation parameters to see whatwill feel best during this extended period. For example, the MDA mightallow the patient to scale the intensity by 0.9, the pulse width bypulse width by 0.8, and the frequency by 0.85, as these scalars whenmultiplied are approximately equal to the 0.6 scalar computed by the MDA170, and thus are consistent with the power savings the patient's end oflife choice requires.

While such new stimulation parameters may not be optimal for thepatient, they would presumably be better than no stimulation at all, andthus allowing the patient to “get by” until they can reach theirclinician to discuss receiving an IPG replacement. In light of theimportance of these scaled settings, the MDA 170 may not, after use ofthe set end of life option 534, allow the patient to further use the MDAto change stimulation parameters, or may at least warn the patient thatpower saving stimulation parameters are in effect before they arechanged.

A rechargeable battery performance GUI 540 results from selecting option504 in the IPG battery performance GUI 500 (FIG. 10A), and is shown inFIG. 10C. Also shown is a rechargeable battery history file 542maintained by the MDA 170, which includes the stimulation parameters (I,f, pw, active electrodes and polarities), the battery voltage (Vbat),and the battery recharge current (Ibat), which are all time stamped.Vbat and Ibat as noted earlier comprise part of IPG data log 220 (FIG.7A) as transmitted from the IPG to the external device 140, and would beaccessible to the MDA 170 via IPG file log 250. The stimulationparameters can either come from the MDA 170 or from the IPG, similar tothe primary battery history file 522 of FIG. 10B.

As shown in FIG. 10C, the rechargeable battery performance GUI 540 mayimmediately notify the patient of certain useful parameters that apatient might wish to review (544), such as the average chargingfrequency (F), i.e., the average number of times the IPG battery hasbeen charged by the external charger over some time period, such as aweek for example, and the average time (T) of each external chargercharging session. These parameters 544 may also comprise selectableoptions.

The MDA 170 in conjunction with the rechargeable battery history file544 can calculate the average charging frequency F by averaging thetimes between subsequent charging sessions, the beginnings of which canbe determined by noting where values for Ibat are reported in therechargeable battery history file 542 after pauses. For example, it isseen that a charging session began at time t5 (as Ibat is reported aftera pause), and that the next charging session began at time t23. As suchthese charging sessions were separated by a time t23−t5 (say 3.3 days).The time between other subsequent charging sessions can likewise bedetermined by the MDA 170 (e.g., 3.0 days, 3.7 days, etc.), with thevarious times averaged (e.g., to determine an average time betweencharging sessions (e.g., 3.3 days). From this average, a chargingsession frequency F over a suitable time period (e.g., 2.1 chargingsessions/week) can be determined and displayed (544).

The MDA 170 can calculate the average time for charging T byascertaining the time between when Ibat appears after a pause (t5) andthen ceases (t6), i.e., t6−t5. These active charging time periods(t6−t5; t25−t23) can then be averaged to determine T.

When computing the average frequency F and time T (544), the MDA 170 mayconsider the entirety of the data in the rechargeable battery historyfile 542, but may also only include data over a recent time period(e.g., one month) better indicative of the patient's recent stimulationparameters and IPG power draw.

Alternatively, when computing the average frequency F and time T (544),the MDA 170 may consider only portions of the primary battery historyfile 542 that match or are close to the patient's present stimulationsettings, which portions would generally have involved power draws inthe IPG similar to the patient's current stimulation settings.Specifically, the MDA 170 may consider and use in the F and Tcalculations only entries in the rechargeable battery history file 544that match or are close to a charge rate (R; charge/time) currentlyexperienced in the IPG in light of the stimulation parameters.Calculating the charge used at each entry in the rechargeable batteryhistory file 542 (C) (see FIG. 10B) is also helpful here. Thus, the MDA170 may determine the relevant time periods for the F and T calculationas discussed earlier. The MDA 170 then preferably determines the chargerate R at least during non-charging periods (e.g., the sum of C7 toC22/t22−t7), although charge values during charging periods (e.g., fromt5 to t6) could be considered as well. The MDA 170 then determines andexcludes periods in the file 542 have charge rates R that don't match orthat aren't close to the patient's current charge rate R′, which can bedetermined by assessing entries in the file after the last chargingsession (e.g., from t26 forward: (C26+C27)/(t26−t27)). Once theseportions of file 542 are excluded, the MDA 170 can then average theremaining relevant time periods as discussed above to determine valuesfor F and T (544) that better match the patient's present stimulationsettings.

Calculations for determining F and T at 544 can also involve the batteryvoltage Vbat in the rechargeable battery history file 542. Vbat will ofcourse drop during periods when the battery 14 is not being charged(e.g., from t7 to t22), and the slew rate (S) at which Vbat is droppingduring such periods can be determined (e.g., S8 =Vbat8−Vbat9/t9−t8), andadded to the rechargeable battery history file 542. While the batteryslew rate can be determined for each entry in the file 542, it may alsoonly be necessary to determine a single battery slew rate for eachnon-charging period. This could occur by determining Vbat at thebeginning and ends of each of these periods (e.g., Vbat7 and Vbat22),and dividing their difference over the elapsed time (e.g.,S22=(Vbat7−Vbat 22)/(t22−t7)). The MDA 170 could also curve fit thebattery voltages (e.g., Vbat7 through Vbat22) with their correspondingtime stamps (e.g., t7 through t22), with the slope of this correlationcomprising the slew rate for the non-charging period.

Regardless of how battery slew is determined, the MDA 170 can againdetermine and exclude periods in the file 542 having battery slew ratesthat don't match or that aren't close to the patient's current batteryslew rate S′, which again can be determined by assessing the last ormost recent entries in the file 542. Once these portions of file 542 areexcluded, the MDA 170 can then average the remaining relevant timeperiods to determine values for F and T (544) that better match thepatient's present stimulation settings.

Further refinements to the calculation of F and T (544) can be made bythe MDA 170 by considering the magnitude of the battery voltage Vbat.This can be useful because it cannot always be assumed that the battery14 is at the same low level when charging begins, nor can it be assumedthat the battery will always be charged to the same high level whencharging ends. Assume for example that Vbat is normally around 4.0 Vafter charging (e.g., at t26) and is normally around 2.0 V beforecharging (e.g., at t22). If a patient used his external charger earlierthan necessary in some instance (e.g., when Vbat=3.0 V), then thefrequency (F) and time (T) associated with that charging session wouldbe unusually short. A patient may also not fully charge the battery(e.g., to Vbat=4.0 V), which again would render values for F and T thatwould be shorter than normal. Accordingly, the MDA 170 may assess Vbatfor unusual values in the rechargeable battery history file 544, andexclude portions of the file 542 associated with those voltages from theaverage F and T calculations displayed at 544. This assessment mayexclude portions where Vbat is too high or too low at the beginning ofcharging, or too high or too low at the end of charging, or where thedifference between Vbat at the beginning and end of charging is too lowor too high.

The estimated time to a next charging session is also displayed at 546.As shown in FIG. 10D, this also can be calculated by the MDA 170, andcalculating the charge rate (R) or battery slew rate (S) can also behelpful here. The MDA 170 can determine such rates for each non-chargingperiod, as well as the duration t of those periods (e.g., t22−t7), thusarriving at a number of data points (R,t) or (S,t). The MDA 170 cancurve fit these data points (550), as shown in the graph at the bottomof FIG. 10D. Portions of the data reflecting unusual values for Vbat maybe excluded when determining such correlations as discussed above.

The MDA 170 can then consider the charge rate or slew rate R′ or S′currently being used by the patient's IPG, and using curve 550,determine the time between charging for such settings (t′). Calculatingthe next time at which the IPG will need to be charged (546) thenrequires the MDA 170 to review the rechargeable battery history file 542to determine when the IPG was last charged (e.g., t25); to determine thecurrent time (e.g., t34); to determine how far the patient is into timeperiod t′ (i.e., t34−t25); and to subtract this value from t′, which canbe displayed at 546.

Further refinements to the next charging time estimation (546) can bemade by the MDA 170 by considering the magnitude of the battery voltage,Vbat. For example, curve fitting in each non-charging period canextrapolate or interpolate when the charge rate or battery slew rateduring each of these periods would have crossed known optimal high andlow threshold values for the battery (e.g., 4.0 V and 2.0 V), even ifthey didn't actually do so. These extrapolated or interpolated times canthen determine a duration for each non-charging period (which maydifferent from the true duration of the non-charging period). Thesemodified t values may then be included with the data points (R,t) or(S,t), which are curve fit (550) and which therefore may lead to moreaccurate correlations.

In another refinement to the next charging time estimation (546), thepresent value of the battery voltage Vbat (Vbat′) and/or the value forVbat after the last charging period (e.g., Vbat26) may be considered.This can be important because the above method for time estimation usinga charge rate or battery slew rate may assume that the battery is alwayscharged to a known level (e.g., 4.0 V), when the reality is different.Assume for example that the correlation 550 is premised on theassumption that the battery is charged to 4.0 V, and that currentvoltage of the battery should be 3.2 V. If the rechargeable batteryhistory file 542 shows that the battery had actually last been chargedto 4.2 V, and that the battery is currently at 3.4 V, then the nextcharging time estimation (546) can be lengthened accordingly. This iseasiest to understand using the context of the current battery slew rateS′: if there is a difference of 0.2 V in assumed and actual values as inthe present example, this difference can be divided by the slew rate S′to determine an additional time to add to t′ to render a more accuratenext charging time estimation (546).

If a patient won't be able to charge his PG battery before the estimatednext charging time (546) (because the patient has left his externalcharger at home on a business trip for example), the set next chargingtime option 552 can be used. Similar to the set end of life option 534for the primary battery (FIG. 10B), the set next charging time option552 will allow a patient to input a convenient time for a nextrecharging, and the MDA 170 will scale the stimulation parametersaccordingly and transmit them to the IPG to reduce power consumption inthe IPG. This process may be essentially the same as described earlierfor the primary battery in that it involves calculating a scalar basedon the current time estimated to a next charge using the patient'scurrent stimulation settings (in 546), and the new time entered by thepatient in option 552. As with option 534, option 552 might involveautomatically scaling one or more stimulation parameters consistent withthe calculated scalar, or allow the patient to scale them consistentwith the calculated scalar. Also similar to option 534, the MDA 170 maynot allow the patient to further use the MDA to change stimulationparameters, or may at least warn the patient that power savingstimulation parameters are in effect.

The rechargeable battery performance GUI 540 may also provide options560 and 570 to allow a patient to review other aspects of charging.Option 560 for example allows the patient to review the effect ofstimulation settings on charging performance, which information may bedisplayed graphically, and which may for example focus on intensity, thestimulation parameter that the patient is most likely to modify with theMDA 170. As shown in FIG. 10D, option 560 might for example displaygraphs showing the effect of intensity (I) on both charging frequency(F) (562) and time of charging (564) (T), such as are reported at 544.

To determine these correlations, the MDA 170 may disregard entries inthe rechargeable battery history file 542 that do not match thepatient's other current stimulation parameters (e.g., pulse width pw′and frequency f′), or may choose to process only entries having pulsewidths or frequencies that have been consistently used by the patient asreflected in file 542. Or the MDA 170 may allow the patient to reviewthe correlations 562 and 564 based on a selected pulse width andfrequency, and then disregard non-matching entries. With certain entriesin the rechargeable battery history file 542 disregarded in thesemanners, the MDA 170 can determine remaining non-recharge periods inrechargeable battery history file 542 consistent with pw′, f′ (e.g.,t7−t22); average the intensities during these periods; calculate Fduring these periods to arrive at data points (I, F); and calculate Tafter these periods to arrive at data points (I, T). These data pointscan then be curve fit to correlate them, which correlations can bedisplayed 562 and 564 for the patient as shown. Current estimations forF′ and T′ may also be shown for the intensity value for patient iscurrently using (I′), which may also comprise the average chargingfrequency (F) and time (T) appearing at 544.

The coupling/efficiency option 570 allows the patient to see howefficient various charging sessions have been, e.g., how well theexternal charger has been coupled to the charging coil 32 in the IPG.Poor coupling results in poor charging efficiency and weak charging ofthe battery 14, and can result from the external charger beingmisaligned with the IPG. See, e.g., U.S. Patent Application Publication2013/0096652. Thus, the patient can review data presented at this option570 to understand if he can be more attentive to aligning the externalcharger during a charging session to more quickly charge the battery. Inthis regard, it is useful for the MDA 170 to have an establishedbaseline 572 indicative of good coupling, which is represented as 100%in the depicted graph. This 100% value can represent the battery chargecurrent Ibat that results during an initialization or test period inwhich the external charger is carefully placed directly over the centerof the IPG, at which point the external charger is turned on to generatea magnetic charging field. The MDA 170 may prompt the patient to performthese initialization or test steps upon first executing the MDA 170 atthe external device 140. Providing a patient-specific baseline 572 inthis manner is useful, because different patients will have their IPGsimplanted at different depths and orientations, and so a good, efficientvalue for Ibat will vary from patient to patient.

Once this coupling baseline has been determined and stored with the MDA170, the MDA can thereafter review the rechargeable battery history file544 to determine when charging sessions have occurred (e.g., t5 to t6;t23 to 25, etc.), and average the values for Ibat during these periods.These Ibat values can then be ratioed with the baseline 572 to determinethe displayed percentages. Notice for example that charging current Ibatas measured by the IPG during the third charging session is about 75% ofIbat measured during initialization or test. The patient would concludefrom this that the coupling between the external charger and the IPG hadbeen relatively poor during this charging session.

While reference has been made to various files (324, 328, 404, 522, 542)in explaining operation of the MDA 170, it should be understood thatthese files may represent subsets or supplementation to the IPG log file250, and so such files may either be stored in association with the IPGlog file 250, or could simply comprise different portions of the logfile 250. It has nonetheless been convenient to discuss such filesseparately so that only relevant portions of the IPG log file 250 areshown to explain different features of the MDA 170. Such files, like IPGlog file 250, may also be stored in memory 232 (FIG. 7B), and hence alsoaccessible to and populatable by the MDA 170.

One skilled in the art will understand that the disclosed medical deviceapplication will comprise instructions that can be stored onnon-transitory machine-readable media, such as magnetic, optical, orsolid-state discs, integrated circuits, tapes, etc., and which can beexecuted on the external device. Examples of likely storage deviceshaving machine-readable media which would store the disclosed medicaldevice application include the external device (e.g., after it isdownloaded, on its hard drive), or an Internet or other network server,such as an implantable medical device manufacturer's server or an appstore server, which a patient can access to download the medical deviceapplication to his external device as noted previously. However, otherstorage devices could include disks, memory sticks or modules, which maybe portable or which may be integrated within other computers orcomputer systems.

Control circuitries operable in the IPG and external device can comprisea microcontroller, microprocessor, or other logic circuitries (e.g.,FPGAs) capable of executing the medical device application as disclosedherein. Such control circuitries can in one example comprise a Part No.MSP430 microcontroller manufactured Texas Instruments, Inc., asdescribed in the data sheet submitted with the Information DisclosureStatement included herewith, which data sheet is incorporated herein byreference in its entirety.

Although various Graphical User Interfaces (GUIs) were disclosedseparately for ease of illustration and discussion, one skilled willunderstand that these GUIs all constitute portions of the GUI for theMBA.

Although particular embodiments have been shown and described, it shouldbe understood that the above discussion is not intended to limit thepresent invention to these embodiments. It will be obvious to thoseskilled in the art that various changes and modifications may be madewithout departing from the spirit and scope of the present invention.Thus, the present invention is intended to cover alternatives,modifications, and equivalents that may fall within the spirit and scopeof the present invention as defined by the claims.

What is claimed is:
 1. A system, comprising: an implantable medicaldevice (IMD); and a machine-readable medium configured to be executed onan external device in wireless communication with the IMD and storinginstructions to cause control circuitry in the external device to:receive dosage data that is indicative of a dosage of a medication takenby a user; and correlate the dosage data with a stimulation parameterthat is utilized by the IMD.
 2. The system of claim 1, wherein themachine-readable medium further comprises instructions to cause thecontrol circuitry to provide a graphical user interface (GUI) thatenables entry of the dosage data.
 3. The system of claim 1, wherein theinstructions to cause the control circuitry to correlate the dosage datawith the stimulation parameter comprise instructions to cause thecontrol circuitry to correlate a first time corresponding to the dosagedata with a second time corresponding to the stimulation parameter. 4.The system of claim 3, wherein there is an offset between the first timeand the second time that is related to a time period required for themedication to become therapeutically effective after it is taken by theuser.
 5. The system of claim 1, wherein the machine-readable mediumfurther comprises instructions to cause the control circuitry to displaythe correlation between the dosage data and the stimulation parameter.6. The system of claim 1, wherein the machine-readable medium furthercomprises instructions to cause the control circuitry to estimate abaseline value of the stimulation parameter that will be appropriate forthe user when the medication is no longer taken by the user based on thecorrelation.
 7. The system of claim 1, wherein the machine-readablemedium further comprises instructions to cause the control circuitry totransmit an adjusted value of the stimulation parameter to the IMD basedon the receipt of dosage data using the correlation.
 8. The system ofclaim 1, wherein the stimulation parameter comprises stimulationintensity.
 9. A method, comprising: receiving, at an external devicethat is configured to communicate with an implantable medical device(IMD), dosage data that is indicative of a dosage of a medication takenby a user; correlating the dosage data with a stimulation parameter thatis utilized by the IMD; and transmitting an adjusted value of thestimulation parameter to the IMD based on the receipt of dosage datausing the correlation.
 10. The method of claim 9, further comprisingproviding a graphical user interface (GUI) that enables entry of thedosage data.
 11. The method of claim 9, wherein correlating the dosagedata with the stimulation parameter comprises correlating a first timecorresponding to the dosage data with a second time corresponding to thestimulation parameter.
 12. The method of claim 11, wherein there is anoffset between the first time and the second time that is related to atime period required for the medication to become therapeuticallyeffective after it is taken by the user.
 13. The method of claim 9,further comprising displaying the correlation between the dosage dataand the stimulation parameter.
 14. The method of claim 9, furthercomprising estimating a baseline value of the stimulation parameter thatwill be appropriate for the user when the medication is no longer takenby the user based on the correlation.
 15. The method of claim 9, whereinthe stimulation parameter comprises stimulation intensity.
 16. Amachine-readable medium configured to be executed on an external devicein wireless communication with an implantable medical device (IMD) andstoring instructions to cause control circuitry in the external deviceto: receive dosage data that is indicative of a dosage of a medicationtaken by a user; correlate the dosage data with a stimulation parameterthat is utilized by the IMD; and cause an adjusted value of thestimulation parameter to be transmitted from the external device to theIMD based on the receipt of dosage data using the correlation.
 17. Themachine-readable medium of claim 16, wherein further comprisinginstructions to cause the control circuitry to provide a graphical userinterface (GUI) that enables entry of the dosage data.
 18. Themachine-readable medium of claim 16, wherein the instructions to causethe control circuitry to correlate the dosage data with the stimulationparameter comprise instructions to cause the control circuitry tocorrelate a first time corresponding to the dosage data with a secondtime corresponding to the stimulation parameter.
 19. Themachine-readable medium of claim 18, wherein there is an offset betweenthe first time and the second time that is related to a time periodrequired for the medication to become therapeutically effective after itis taken by the user.